A Study to Compare Different Antibiotics and Different Modes of Fluid Treatment for Children With Severe Pneumonia

Summary

Pneumonia is one of the top causes of death in children aged below 5. More than 10% of children with severe pneumonia die. We are not sure that the currently recommended antibiotics used in children with pneumonia are the most effective. No studies have been carried out to find out whether children with pneumonia should be given intravenous (IV) fluids or nasogastric (NG) feeds.

The SEARCH trial aims to find out which antibiotics and modes of feeding are the most effective in treating children with severe pneumonia and therefore helping reduce mortality.

Conditions

• Pneumonia

Interventions

DRUG

Benzyl penicillin

Benzyl penicillin is a penicillin antibiotic.

DRUG

Gentamicin Sulfate

Gentamicin is an aminoglycoside antibiotic.

DRUG

Ceftriaxone

Ceftriaxone is a third generation cephalosporin antibiotic active against a wide range of gram negative and positive bacteria.

DRUG

Amoxicillin Clavulanate

Amoxicillin Clavulanate is a combination of amoxicillin, a β-lactam antibiotic, and potassium clavulanate, a β-lactamase inhibitor.

OTHER

Intravenous fluid

Maintenance fluids administered for at least 24 hours.

OTHER

Nasogastric feeds

Feeds given via nasogastric tube. Feeds may include cow's milk, breast milk, porridge, formula among others.

DRUG

Ampicillin

Ampicillin is a penicillin-type antibiotic.

Sponsors & Collaborators

• University of Nairobi

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• National Institute for Health Research, United Kingdom

  collaborator OTHER_GOV

• Department for International Development, United Kingdom

  collaborator OTHER_GOV

• Medical Research Council

  collaborator OTHER_GOV

• Wellcome Trust

  collaborator OTHER

• Kenya Ministry of Health

  collaborator OTHER_GOV

• University of Oxford

  lead OTHER

Principal Investigators

• Ambrose Agweyu, PhD · KEMRI-Wellcome Trust Research Programme, University of Oxford

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

2 Months

Max Age

59 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-19

Primary Completion

2024-04-05

Completion

2024-04-05

Countries

• Kenya

Study Locations